Stereotactic Body Radiotherapy for Unresectable Pancreatic Cancer
Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Unresectable Pancreatic Cancer
1 other identifier
interventional
1
1 country
1
Brief Summary
This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy (SBRT) for the treatment of unresectable pancreatic cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable pancreatic-cancer
Started Sep 2008
Typical duration for not_applicable pancreatic-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 29, 2011
CompletedFirst Posted
Study publicly available on registry
May 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedResults Posted
Study results publicly available
February 22, 2018
CompletedFebruary 19, 2020
February 1, 2020
3.8 years
April 29, 2011
January 24, 2018
February 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Local Control Rate
Local recurrence is defined as tumor recurrence within the planning target volume. Local control rate will be evaluated by imaging techniques such as CT or MRI. Local recurrence will be defined as an increase of \> 20% in tumor size. If necessary, a Positron Emission Tomography scan may be used to aid in diagnoses of local tumor recurrence.
5 years
Secondary Outcomes (1)
Late Toxicity Rate
5 years
Study Arms (1)
A
EXPERIMENTALStereotactic Radiation to Pancreas
Interventions
Suggested fractionation is 20-25 Gy / 1 fraction OR 30-36 Gy / 3 fractions (10-12 Gy per fraction) OR 40-45 Gy / 5 fractions (8-9 Gy per fraction)
Eligibility Criteria
You may qualify if:
- Patient age \>= 18 years
- Performance status of 0-3
- Unresectable pancreatic cancer
- Maximum tumor diameter \< 7.5 cm
- Signed study-specific consent form
You may not qualify if:
- Maximum tumor diameter \> 7.5 cm
- Prior radiotherapy to the upper abdomen
- Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females
- Patients with psychiatric or addictive disorder that would preclude obtaining informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mercy Researchlead
Study Sites (1)
St. John's Mercy Medical Center
St Louis, Missouri, 63141, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Kathy Baglan
- Organization
- Mercy
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Radiation Oncologist
Study Record Dates
First Submitted
April 29, 2011
First Posted
May 3, 2011
Study Start
September 1, 2008
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
February 19, 2020
Results First Posted
February 22, 2018
Record last verified: 2020-02